This column is a collaboration with DoubleBlind, a print magazine and media company at the forefront of the psychedelic movement.
Erinn Baldeschwiler had already been having a rough go of it. A mother of two teens, she was going through a divorce, moving out of her house, and splitting from her business partner all as the severity of the Covid-19 pandemic was becoming a reality. Amid it all, she was diagnosed with stage four, triple-negative metastatic breast cancer. The doctors told her that even with chemotherapy every week — something which she knew would severely impact her quality of life — and immunotherapy every two weeks, she likely had about two years to live.
“It was devastating,” says Baldeschwiler, 49. “I thought, what if I’m not going to be here for my kids? A dear friend passed very suddenly, unexpectedly from cancer a few years back and I just know the pain that it leaves behind. It was really, really heavy.”
Now Baldeschwiler, along with Michal Bloom, another cancer patient diagnosed with stage 3 ovarian cancer in 2017, their palliative care physician, Dr. Sunil Aggarwal, and his clinic, AIMS Institute, are suing the Department of Justice and the Drug Enforcement Administration. Baldeschwiler and Bloom want to try psilocybin, the psychoactive component in psychedelic mushrooms, in a therapeutic context for what’s sometimes called “end-of-life distress,” depression, anxiety, and other mental health challenges that can come along with a terminal diagnosis.
Kathryn Tucker, one of seven attorneys on the case, says Baldeschwiler and Bloom have the right to access psilocybin under Washington state’s Right to Try law, a law which permits patients with a terminal illness to access drugs that are currently being researched, but not yet approved. The federal government, she says, is wrongfully interfering with that right.
According to Tucker, who has devoted much of her career to helping pass and reform legislation meant to ease the suffering of those at the end of their lives, states are the primary authority for the regulation of medicine. And yet, in January, Tucker says, when she wrote to the Drug Enforcement Administration, on behalf of Aggarwal, Baldeschwiler, and Bloom, asking them how they should go about accessing psilocybin, the administration wrote back saying they couldn’t because psilocybin is a Schedule I drug on the Controlled Substances Act, the most restrictive category defined as drugs with “no medical use” and a “high potential for abuse.” (Typically, physicians with terminal patients would go straight to a manufacturer to get access to a drug under a state’s Right to Try law, but they needed to write to the Drug Enforcement Administration about the process for access since psilocybin is federally illegal.)
In addition to Washington state, 40 states have Right to Try laws, although they’re all worded slightly differently. (Some use language like “terminally ill” while others say “life threatening,” which could change who qualifies.) Overlaid on top of these state Right to Try laws is a federal Right to Try law, which President Trump signed in 2018. In this case, Tucker and the fellow attorneys are primarily focused on patients’ rights under Washington’s Right to Try law, but are using the federal Right to Try law to bolster their argument.
Both the Washington law and the federal law state that terminal patients can access drugs that are not yet approved by the Food and Drug Administration so long as they’ve successfully made it through the first phase of an FDA-approved clinical trial and are currently being investigated. Psilocybin is currently in the final phase of research before FDA approval, and has shown so much promise for treatment-resistant depression and major depressive disorder that it’s been granted “breakthrough therapy” status by the FDA.
“The DEA just did not know about or did not understand Right to Try and this lawsuit is something of an educational vehicle,” Tucker says. Yes, she says, psilocybin is on the Controlled Substances Act, but in the hierarchy of legislation, The Federal Food, Drug, and Cosmetic Act, which Right to Try falls under, trumps the Controlled Substances Act. Tucker says DEA officials just don’t understand that or are behaving as though they don’t. (The Department of Justice declined to comment for this story.)
“I don’t want my diagnosis to be upsetting and dark and hopeless for my kids,” says Baldeschwiler. “So I need to be in a space where I am not hopeless and there is peace. I know for certain if I’m negative and ‘woe is me,’ and desperate and have feelings of like ‘I just want to check out,’ that’s going to make it a hundred times worse.”
Baldeschwiler first got the idea to do psychedelic-assisted psychotherapy from Aggarwal, who she’d found after looking around for more holistic treatment plans in the Seattle, Washington area. Aggarwal discovered what he says is the extraordinary potential of psilocybin to help cancer patients when working with the psilocybin research group at New York University.
Researchers, going back to the late 1950s, found psychedelics such as psilocybin and LSD showed promise for end-of-life distress as well as a host of other mental health conditions, from alcoholism to trauma. Much of this research, however, is not considered valid by the Food and Drug Administration because it did not follow their current protocols.
After Richard Nixon signed the Controlled Substances Act into law in 1970, there was essentially a decades-long ban on psychedelic research. It was a landmark study, published in the Journal of Psychopharmacology, in 2006 — showing psilocybin holds promise for end-of-life distress in cancer patients — that largely jumpstarted what’s now known as the “Psychedelic Renaissance,” the second wave of psychedelic research in the U.S. since the 60s. The study found that after two or three psilocybin sessions, a majority of participants had significant and positive changes in their mood, while 33 percent rated the experience as the most spiritually significant experience of their life, comparable to the birth of a first child or the death of a parent. Since then, this research has continued with the same results in trials at Johns Hopkins and New York University.
“Many, many patients come to me wanting this,” says Aggarwal of psilocybin-assisted psychotherapy. “They read about it in the news or in Michael Pollan’s book.” He says it’s hard to predict, but there’s surely millions of terminally ill patients who could benefit from psilocybin therapy. In 2021 alone, an estimated 1.9 million Americans will be diagnosed with cancer, according to the National Cancer Institute. That doesn’t even take into account, says Aggarwal, all the other terminally ill patients, such as those with Lou Gehrig’s disease, whom he also works with.
Susan Patz, a 62-year-old woman with Lou Gehrig’s disease, filed an Amicus brief, a statement which can be filed to the court by someone in favor of a particular side of a case, for this lawsuit. Patz lives in the town of Monroe, Washington, where her husband John is now her caretaker as she slowly loses agency over her body and even her ability to breathe and swallow.
“Because of the ALS, I have had to give up a lot of the activities I was passionate about,” she wrote to the court in a brief filed on May 24th. “I loved gardening, and I used to delight in driving the tractor around our property. I loved to swim at the YMCA five days a week. I loved cooking and trying new recipes. I can no longer do any of those things.” She often stays up until 3 or 4 in the morning, because she can’t sleep; she used to be “foodie,” but now doesn’t want to eat or even see friends for fear that they’ll see her as a “sick person.”
“I am desperate to try something that will work, something that will enable me to experience joy and pleasure again,” she wrote to the court. “If the Right-to-Try laws don’t allow someone like me the chance to try something that may help alleviate my suffering, then what good are they?”
On June 21st, the Department of Justice will file a brief on behalf of the Drug Enforcement Administration. On July 12, the petitioners — Aggarwal and his patients — will be given the opportunity to reply. And then, likely in September, the oral argument will take place in which, Tucker says, they may get their first insights into where the court stands on the case. She’s hopeful that perhaps they won’t even get that far, though, because the Drug Enforcement Administration will reach out with the intention of finding a resolution.
Either way, Tucker says, if the case passes, the next doctor and patient who want access to psilocybin for end-of-life distress shouldn’t need to take it to court again. If they succeed in Washington, then, she says, doctors and patients in states with Right to Try laws should be able to access psilocybin.
There’s many unknowns, however, about how doctors and patients would go about notifying the DEA when they’re going to conduct psilocybin therapy — and how they would access the psilocybin itself. Currently, under Right to Try laws, doctors don’t need government approval at all — they can go straight to manufacturers to request access to a drug that’s under investigation for their patient. But the process might be different for psilocybin and a host of practical issues exist, too, such as that it’s difficult to find federally-licensed labs making synthetic psilocybin as there’s no publicly available directory. At this point, Tucker says, they’re just focused on taking things in “small bites.”
“It kind of kills me that I have to be dying to even possibly have access to this medicine when I think it could be incredibly helpful for so many people that maybe don’t fall into that category,” says Baldeschwiler. “I truly, truly am hoping that we have some open minds and open hearts with regards to the DEA and that they honor the intent and the letter of the law because we fall within it.”